Contents

OUR TEAM

Name: Koop Bills

Name: Tyler Lent

Name: Omar Maranon

Name: Maria Hanna

Name: Israel Zaldivar

Name: Your name

LAB 2 WRITE-UP

Device Image and Description

Description: Similar to a catheter, includes a pressure sensor to aware the person of how full the bladder is as well as a valve for the person to control when they empty their bladder, allowing for more independence of those who suffer with urinary incontinence

Technical and Clinical Feasibility

Sizing could be an issue as what we are trying to do is essentially create a catheter that has sensors built into it. These sensors need to be able to operate in a moist environment with consistent reliability and give consistently accurate results. We also will find difficulties in finding a non-intrusive way to power our device as our large goal is to make this a product that wouldn't require any kind of surgery.

Things that could go wrong:

Shortage- Because we need to introduce electric components into a wet environment we, by proxy, run into issues where the device that we have in mind could short out which could lead to system failure or, even more seriously, burns.

Tearing- There is a possibility that if the catheter doesn't necessitate a specialized doctor to insert the device that the person doing the inserting could tear the urethra if not careful.

Infection- There is a high risk of infection as we plan our catheter to be a device that could potentially stay in the body and as such it is possible that we not only introduce bacteria to the urethra, but that we also provide a surface that bacteria could grow off of.

Clinical Feasibility

Will it work in the clinic?

Realistically, yes. Catheter insertion is a very standard "procedure" requiring very minimal skill for the person doing the insertion.

What are the clinical risks?

-As with the technical risk there is the chance that the person inserting the catheter could introduce foreign bacteria into the patient.

-There is the possibility that the doctor could make mistakes when inserting or removing the catheter, as such it might behoove us to include a "instructional video" related to how best to insert and operate our device.

Have similar products been in a clinical trial? How long was the trial?

-Foley catheters have existed since the late 60's however the improvement that we are trying to conceive has not yet been tried in this scope.

Using the fundability worksheet chart, determine the scores (0 - 3) for technical feasibility and clinical feasibility and provide support for scores.
Technical feasibility: 2 as discussed above all the required technologies that we would need for our catheter are already in market, and moreover what we really want to do with our product is not out of the realm of possibility
Clinical feasibility: 2 or 3 We are being conservative with the inclusion of a two because the process for using Foley catheters is well established.

Market Analysis

Value Creation

Our prototype increases the independence of the user as they would no longer have to rely on a caretaker to go to the restroom, as well as improve their self esteem due to no longer needing to use external devices to help urinary incontinence. As such, it is a better investment than diapers due to the fact that our prototype only has to be swapped every couple of weeks as opposed to a diaper which would need to be changed multiple times a day. It’s also better than normal catheters as the need for replacement is a few weeks longer than your average catheter. It also has a pressure sensor and a controllable valve which allows the consumer to decide for themselves when going to do their daily duties. This results in a higher demand from the consumers and an easy overtaking of any competition in the market.

Manufacturing Cost

Foley Catheter - $ 0.98
Pressure Sensor- $2.06
Electroactive Polymer- as there is no released price for these as of yet we can only speculate about including them in the final design.
Plastic- $0.20 cents per pound
Battery- $11.00 We have a battery that we would like to integrate but as of current there is no available price info (High-power lithium ion microbatteries from interdigitated three-dimensional bicontinuous nanoporous electrodes) because of the technical complexity of one of these batteries we will conclude that a good estimate would be to use the price of a "similar" product a xeno lithium ion battery.
Micro release valve- $3.50

$ 30.00, our component cost is about $17.55 we would also have to factor in labor but assuming that we can eventually get to the point where we are able to produce our product without outsourcing for the components we are willing to say that a good estimate for charge is as expressed above. We would like to keep our price relatively low to be as competitve as possible considering that the best alternative, i.e : a regular catheter, is less than a dollar.
Souces:
"Urology Care Foundation - What Is Urinary Incontinence?" Urology Care Foundation - What Is Urinary Incontinence? N.p., n.d. Web. 21 Sept. 2016.

Market Size

An extremely conservative initial market size analysis lands us at $562.5 million (75 million suffer from incontinence, assuming that around 25% of the sufferers switch to our product, with a charge rate of $30 per piece)

Fundability Discussion

Following the criteria, we have derived a score of 243 on Kelvin Ning’s Fundability Criteria Worksheet. Due to little to no communication with potential consumers, we placed at a ONE for Customer Validation. For Market Size in the United States, we came up with a 3, due to after taking everything that could affect market size and conservative thinking, we still came up with nearly $700 million per year. Competition is extremely minimal in our market, as our closest competitors are diaper producers and catheters, both of which do not take full advantage of the technology available and are rather medieval compared to other devices in other markets. For IP position we determined we would have 3 as our product is similar to catheter which has patents already in place. We would kinda be piggybacking off that one as well as filing a patent to cover our additions.